—#180727

Product

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K182077
Affected lot / code info: All Lots

Why it was recalled

There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

Root cause (FDA determination)

Device Design

Action the firm took

The firm originally sent a "Medical Device Correction " letter to affected consignees on December 5, 2019. On November 9, 2020, a "Update - Medical Device Correction" letter was sent out to all affected customers. The purpose of the letter was to update consignees that since the initiation of the recall (12/5/2019), Medtronic had developed a fix to permanently correct the issue associated with the Mazor X Surgical system. The notice further stated that upon availability of parts, Medtronic will schedule a service visit to correct the system at no charge. Medtronic expects to initiate these service visits within the next six months. Pending completion of service to correct the Positioner Type II system, continue to follow the modified mounting instructions. The firm requested that consignees do the following: 1. Please sign and date the Customer Confirmation Form enclosed with this letter to confirm that you have reviewed the information included in this notification with all users of the affected Mazor X" Surgical System, including physician users. 2. Return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. 3. If you have any questions regarding this notification, please contact Medtronic at 1-888-826-5603. Medtronic will initiate service visits to correct systems on-site at customer locations when the kits become available. This is expected to begin by February 2021. View spreadsheet for updated

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,

Timeline

Recall initiated: 2019-12-05
Posted by FDA: 2020-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.